OS Therapies has reached agreement with the FDA, MHRA, and EMA on an adaptive design for its Phase 3 trial of OST-HER2, a gene-edited cancer immunotherapy targeting metastatic osteosarcoma. The company will start this trial in late 2026 and plans a key FDA meeting after submitting 3-year survival data. OS Therapies also accepted MHRA's request to lead its participation in Project Orbis, a global initiative to speed up oncology drug approvals through coordinated regulatory reviews. OST-HER2 holds multiple designations including Orphan Drug and Fast Track, and if approved, OS Therapies could receive a valuable Priority Review Voucher to sell. This alignment and Project Orbis involvement aim to accelerate OST-HER2's availability in the US, UK, and Europe.
OS Therapies' recent regulatory progress is provided here with a snapshot of the Health sector on Pluang as of Sep 17, 2026 17:02 WIB: Among 91 priced US health stocks, 59 rose and 27 fell. Ascendis Pharma (ASND) traded at USD 239.50 with a 3.31% decline and a strong 91% sell order activity, contrasting with Sana Biotechnology (SANA) at USD 3.00 gaining 2.74% but seeing 86% sell orders. American Well Corp (AMWL) rose 2.03% to USD 13.60, holding the longest typical Pluang hold time of 61 days in this group.
Oracle reported a strong quarter with revenue growth of nearly 30% and a surge in cloud infrastructure revenue, yet its shares fell due to concerns over high capital expenditures and increased debt. Despite the selloff, Wall Street analysts remain bu...
MiMedia Holdings Inc. has appointed Stephen Andrews, a seasoned telecom executive with over 25 years at British Telecom and extensive board experience, as a new Board Director. Andrews brings deep industry knowledge and a vast global network, expecte...
The FDA has approved an updated label for IBTROZI (taletrectinib), a treatment for ROS1-positive non-small cell lung cancer (NSCLC), reflecting a median duration of response of nearly 50 months in TKI-naïve patients from the TRUST-I study. This updat...
Oreterra Metals Corp. has finished its initial Phase 1 drilling at the Trek South porphyry copper-gold prospect in British Columbia's Golden Triangle, completing 13 holes totaling 4,500 meters. Early visual results show extensive porphyry-style alter...
Argyle Resources Corp. has successfully completed its 2026 exploration program on the McKay Hill silver-gold property in Yukon, involving soil sampling, rock sampling, and geophysical surveys to expand known mineral zones. The company plans a lidar s...
